Premenstrual Syndrome (PMS) and Mindfulness Stress Reduction Program (MSRP)

NCT05191108 | Completed

• 1 other identifier: Firat Universityyy
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

Premenstrual syndrome (PMS) is a disorder characterized by emotional, physical and behavioral symptoms that increase the severity of the menstrual cycle in women of reproductive age during the luteal phase and disappear spontaneously a few days after the onset of menstruation. Nonpharmacological applications are often preferred to reduce premenstrual symptoms. It has been stated that with the meditation practices of mindfulness, individuals experience less anxiety, depression, anger and lower levels of psychological distress, including anxiety. . It is thought that the mindfulness stress reduction program can reduce the symptoms of PMS by regulating the stress level and emotional balance of women.

Conditions

Premenstrual Syndrome

Keywords

mindfulness; premenstrual syndrome

Outcome Measures

Primary Outcomes (1)

• premenstrual syndrome

  This scale, which was developed by Gençdoğan et al. (2006) for the evaluation of premenstrual symptom complaints, consists of 44 questions in total. The scale has nine sub-dimensions: depressive affect, anxiety, fatigue, irritability, depressive thoughts, pain, appetite changes, sleep changes, and swelling. PMSS is performed by evaluating the person retrospectively, taking into account the status of being "within 1 week before menstruation". The lowest score to be obtained from the scale is 44, and the highest score is 220. High scores indicate an increase in the intensity of PMS. In calculating the scale score, 44 points are considered as No PMS, 45-103 points as PMS Mild, 104-163 points as PMS Moderate, and 164-220 points as PMS Severe Level. Cronbach's α reliability coefficient is between 0.75 for the total scores of the scale and between 0.75 and 0.91 for the subscales. Written permission was obtained from Gençdoğan for the use of the scale.

  UP TO 16 WEEKS

Study Arms (2)

The Effect of mİNDFULNESS Stress Reduction Program on Premenstrual Symptoms

EXPERIMENTAL

In order to prevent bias in the study groups, the Introductory Information Form and PMSS scale will be applied via online Google forms. Participants who meet the criteria will be randomly assigned to the mindfulness stress reduction group (Group 1) and control group (Group 2) in the number determined by power analysis and a simple random number generator program (www.random.org). These experimental and control groups will be recorded by the researchers as a list. Participants participating in the study will be informed about the mindfulness stress reduction application, but they will not be informed about what the mindfulness stress reduction application does (single-blind method). These participants will be asked to sign the consent form by expressing that they can withdraw from the study at any time.

Behavioral: mindfulness stres reduction programe

Control group

NO INTERVENTION

not routinely do anything to reduce premenstrual symptoms

Interventions

mindfulness stres reduction programe BEHAVIORAL

Complaints about PMS and sharing information about these complaints, Practice of breathing focused meditation, mplementation of mindful eating exercises,Raising awareness in daily activities,Teaching the body scanning exercise and repeating this practice during the week with the audio recordings given.Ensuring environmental awareness Ensuring that you live by being aware of the moments experienced during the week, 20 minutes of sitting breathing focused sitting meditation Coping with stress Sharing the experiences of the previous week Implementation of mindful vision practices Explaining the relationship between stress and experienced events.Eating exercises Mindful breathing Ensuring environmental awareness Explaining the importance of thinking about the relationship between stress and their reactions and accepting them without judgment, and sharing the experiences at the end of the day of silence.

Also known as: mindfulness

The Effect of mİNDFULNESS Stress Reduction Program on Premenstrual Symptoms

Eligibility Criteria

• Age: 17 Years - 30 Years
• Gender Eligibility Details: PMS IS ONLY SEEN IN WOMEN
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• be between the ages of 18-30
• Having a score of 45 or more on the PMS scale
• Regular menstruation (between 21-35 days)
• Knowing Turkish (being literate)
• Read and approve the voluntary consent form

You may not qualify if:

• Having any gynecological disease (abnormal uterine bleeding, uterine fibroids, ovarian cysts, hormonal treatment, etc.),
• Having a chronic or physical illness (having serious hearing and vision problems, vestibular disorders that can cause balance loss)
• Having any problem that prevents communication (such as not knowing Turkish, having impairment in hearing, speaking and understanding abilities)
• Receiving a psychiatric treatment (Pharmacotherapy or psychotherapy)
• Do not use pharmacological or non-pharmacological applications to reduce the symptoms of premenstrual symptoms.

Sponsors & Collaborators

• NURDİLAN SENER: lead
• Kırklareli University: collaborator

Study Sites (2)

NURDİLAN

Elâzığ, Eyalet/Yerleşke, 23100, Turkey (Türkiye)

Location

Kırklareli Üniversitesi

Kırklareli, 39100, Turkey (Türkiye)

Location

Related Publications (1)

• Sener Cetin N, Solt Kirca A. The Effect of a Mindfulness-Based Stress Reduction Program on Premenstrual Symptoms: A Randomized Controlled Trial. J Midwifery Womens Health. 2023 Sep-Oct;68(5):604-610. doi: 10.1111/jmwh.13530. Epub 2023 Jun 19.

  PMID: 37335817 DERIVED

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomize Controlled clinical trial

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 13, 2022
• Study Start: February 21, 2022
• Primary Completion: April 21, 2022
• Study Completion: April 30, 2022
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)